Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease (rTMSVR)

September 4, 2023 updated by: Luzerner Kantonsspital

Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease: a Randomized Controlled Pilot-study

We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The short and long-term benefits of this training program will be evaluated. For these purposes, a blinded sham controlled randomized controlled trial will be performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using remote controls, smartphone or tablet. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be tested.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed PD
  2. Hoehn & Yahr I to IV
  3. Age 50-80 years old
  4. written and signed informed consent
  5. dexterous difficulties-

Exclusion Criteria:

  1. Significant medical, psychiatric co-morbidity including dementia as defined by Montreal Cognitive Assessment (MOCA < 21)
  2. Inability to understand the scope of the study and to follow study procedures according to the protocol e.g. complete questionnaires (i.e. due to cognitive problems)
  3. Exclusion criteria for TMS and Sham application, such as current pregnancy, personal history of epilepsy or epileptic fits, and any psychiatric, neurologic, or medical history.
  4. Participation in another interventional trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: real stimulation
The PD patients randomized in the experimental group will receive VBT each time preceded by a real rTMS stimulation.
Other: Transcranial magnetic stimulation
Non-invasive brain stimulation
Sham Comparator: sham stimulation
The PD patients randomized in the control group will receive VBT each time preceded by a sham TMS.
Other: Sham transcranial magnetic stimulation
Non-invasive brain stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DextQ-24
Time Frame: 3 weeks
standardized patient self-rated outcome measure (PROM) for evaluating dexterity related ADL in PD
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nine Hole Peg test (9-HPT)
Time Frame: 3 weeks
The 9-HPT is a standardized, well established, and reliable measure of hand dexterity in patients with PD.
3 weeks
Coin rotation task (CRT)
Time Frame: 3 weeks
The CRT measures fine coordinated finger movements and is a suitable and valid dexterity test in patients with PD.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Tim Vanbellingen, Luzerner Kantonsspital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2020

Primary Completion (Actual)

July 20, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2019-00433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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